IOM and the Clinical Case Definition Committee – A Case for Hope

In August, the NIH Office of Women’s Health announced its intent to contract with the Institute of Medicine (IOM) to form a committee to propose diagnostic criteria for ME/CFS. On Tuesday, December 3, the IOM announced the provisional committee slate for this work. It has been posted and all areinvited to review the slate and provide feedback.

The Association has reviewed the full slate of committee members and is optimistic that this committee will be effective in fulfilling its important mandate.

We’ve reached this conclusion because there is:

Sufficient and diverse clinical experience and expertise with ME/CFS

Patient representation among committee members

Expertise in developing diagnostic criteria and outcome measures

Expertise in the dissemination of information in areas of unmet medical need

Sufficient and diverse clinical experience and expertise with ME/CFS – Eight of the fifteen committee members have significant experience and expertise in ME/CFS, as long time physicians, clinical researchers, and published investigators. Many of them have close ties to the patient community and advocacy organizations. In fact, a number of them signed the anti-IOM contract letter but have agreed to serve to help ensure the best possible outcome.

Patient representation among committee members – Of critical importance is a basic understanding of the severity and complexity of the illness; those with first-hand experience can best express this. Two on the committee have been diagnosed and two have close family ties to ME/CFS. This first-hand knowledge paired with relevant expertise will greatly inform the whole of the committee and their proceedings.

Expertise in developing diagnostic criteria and outcome measures – There is a great need for broadly accepted clinical tools that can accurately define the core signs and symptoms, or reductions in specific functioning, experienced in the ME/CFS population. Currently the tools that exist are not widely used and some (like the Canadian Consensus Criteria or CCC) are limited to those specializing in ME/CFS treatment, of which there are very few. This leaves a majority of doctors lacking the tools they need to objectively detect and diagnose ME/CFS early. Three of the panel members have direct experience in developing case definitions and even more have related, relevant expertise to inform this committee work.

Expertise in the dissemination of information in areas of unmet medical need – Operationalization and widespread dissemination and adoption of a clinical diagnostic tool are critical for the ME/CFS population. When diagnosed early, the chances of recovery improve. This means primary care providers – the first line of defense in our medical system – must understand and be able to diagnose ME/CFS. Without this capability, patients are left to fend for themselves and many have suffered undiagnosed for years as they search for answers. There are members with expertise in screening for disease. It is important to note that in order to be fully effective, the resultant clinical diagnostic criteria must be widely disseminated – reaching doctors that meet the needs of under-served populations. There is significant expertise among committee members in regard to the methodology and service delivery issues that will be encountered with the full and proper distribution and implementation of such diagnostic criteria.

The Solve ME/CFS Initiative believes that the committee proposed for the IOM, with open minds and critical thinking about the evidence coupled with the right inclusive process, can have the impact necessary to make the disease-defining concepts of ME/CFS widely understood and available. Indeed the CCC has provided an important foundation for clinically defining ME/CFS but it is has not been widely used or adopted by the U.S. medical community. The credibility and authority of the IOM – the health arm of the National Academy of Sciences – is critical to making ME/CFS widely recognized and diagnosed by the nation’s medical community.

To review, the IOM was issued a charge with four important aspects that are critically important for progress:

Identify and evaluate the evidence – The research and medical communities have learned much since the CCC was written in 2003. Reviewing and building on it, along with other evidence, will produce a current, scientifically valid criteria for clinical use.

Develop diagnostic criteria for use by clinicians – This is critical to put tools for diagnosis in as many physician’s hands as possible, because the core signs, symptoms and decreases in specific functioning must be “easily” and reliably measured in order to detect an effect.

Look at changing the name of the illness –This is very important as the “Chronic Fatigue Syndrome” name undermines and trivialized the disease. We are hopeful that a recommendation will be made to change the name to a more appropriate and better defining disease name.

Develop an outreach strategy to disseminate the definition nationwide to health professionals – We strongly support this charge, recognizing that most clinicians are uninformed about ME/CFS. Widely distributed diagnostic criteria that has the ‘stamp of approval’ from the IOM will result in wider and faster recognition and diagnosis of ME/CFS.

The Solve ME/CFS Initiative believes that the committee roster demonstrates that the IOM understands the charges and the extreme importance of the committee’s success. And at the same time, we will stay vigilant and engaged in the process. We aim to “stand in the gap” alongside other advocacy groups and individuals as the process unfolds, bringing patients information, informed perspective and opportunities for involvement in the process.

The formation of the IOM committee to develop clinical diagnostic criteria is a strong, unprecedented opportunity in the history of ME/CFS. This important activity can build an emboldened base of federal support, opening the door to validation, funding and future research. There is much urgent work to be done. The Solve ME/CFS Initiative will continue to contribute as we work to fulfill our mission: Making ME/CFS understood, diagnosable and treatable. We look forward to a world free of ME/CFS.

I worry about the change of location on the web, as well as the name change. My doctor, although being one of the three physicians that diagnosed me using the Canadian Consensus Document ( the other two being my Neurologist and Rheumatologist) remains suspicious and critical of the existence of this illness. The other two specialists, in spite of the treatment they were giving me for diagnosed conditions dropped me as a patient immediately, stating there was nothing of they could do for me since I had ME/cfs. They stated they didn’t have enough knowledge of the illness to feel comfortable treating me. I had been suffering weird bouts of inflammation that just didn’t show up on traditional testing procedures, but presented as inflammations and responded to mini medrol packs. I had a serious CNS sleep disorder, severe visual tracking issues, total lack of ability to multi task (walk and talk simultaneously. I had to stop walking, and counting backwards by serial 7s could not be done while walking, or with eyes open. I could no longer walk toe/heel, would reach forward and fall backwards, rapid cognitive fatigue ending in loss of speech, tears, and confusion. Sleep (I liken it more to going out cold than actual sleep. It happens rapidly now as I’ve worsened. I also had suddenly began experiencing sudden loss of ability to write and read, sometimes in the middle of signing my name. I will forget how to spell it, or the wrong symbol would appear instead of what I had intended to write. Other times (also when talking) my thought fluidity would just stop. Blank. What process was forming my words or letters if writing, even the topic, would disappear. I mean my brain was like a. Blackboard that all writing, words, pictures, everything, was erased and blank. No clue what I had been talking about, or intending to talk about. It was/is like turning off s tv set, except you also forgot what was on the screen a second ago. It’s all black. Nothing. An empty space. Oh, and I ramble and have no continuity when writing. I usually spend an hour or two on a comment like this, it’s become that difficult for me. And I end up reading it instead of submitting it because its hideously long, disjointed and embarrassing. I used to be an editor. I made professional people sound intelligent on paper (their strengths weren’t in language arts and mine (laughably) were. I also wrote legal papers and legislative documents. Now everyone thinks I’m an uneducated, emotional, head case with a learning disability. Delusional, hypochondriac, agoraphobic malingerer. The two specialists did assure my gp that they would be there if he needed any advice. Wow. Anyway, my doctor is paranoid and does not lend any credence to the validity of grass roots research findings or claims. He had ordered me, yet again, to prove to him there is current proof that this illness is real, and not something my “sick, agoraphobic attention seeking (pleas/tears for help during frightening occourances) mind” had dreamed up. A skin condition was deemed to be self mutilation and I was declared “seriously sick! In THE HEAD!!!”. My doctor screamed this at me. He screamed it. Yes, I am afraid of my doctor. He has so much power over what happens to me. If something conclusive and validating doesn’t happen in the medical regulatory and educational arena fast I fear for my safety, as he will try another forced exercise regimen, and have me committed as mentally I’ll when I am so much more debilitated by his treatment demands and hoops I have to jump through. I am now unable to walk any further than around my apartment, and am physically nearly bedridden. He believed the work I showed him from research 1st, because it came from the CFIDs association. He proclaimed them “A well respected organization”. Now, with this name change to please solve cfs it sounds grass roots. He will snub his nose at anything I attempt to show him from this very, very important, pivotal cutting edge source of knowledge and research. I am sunk. I am terrified. I can’t even operate a power chair without running off the sidewalk, or my hand spasming from weak, tremorous muscles trying to operate the controls. I can’t physical ride in a car to a specialists office any longer. I fatigue when chewing food. I can’t do anything! I am at thge bottom of a dark, black well from which I fear I will never emerge. I know the water that will fill this well will come, and I will drown, as I am too weak to swim. Even if its to save my life. My body doesn’t work anymore. I Don’t even get tub baths now, for fear of suddenly “going out” and drowning. Or not bring to lift my leg over the edge of the tub and becoming trapped. It took 7 years for me to go from Independent, strong, athletic mom living with my daughter on our own in the Alaskan bush to a disbelieved, utterly abandoned, seriously ill, weak, suffering, frightened helpless human being. What is being done to us is not unlike being treated for sadness with a labotomy. It is abusive, cruel and unusual. Our only crime is being horribly ill. Animals are treated with more compassion and respect than ME/cfs patients. I’m going to be brave and submit this comment. I know how poorly this is written, but it would show such a clear example of what happens to our language centers if only I had something of myself before to compare it to. Does top 20% of my class lend me any credibility? I fear the person that is me is gone, never to return. And that my future entails a far less years of life than I should have left at the age if 52, and that those years will be spent in a steady, torturous decline. I cannot help myself any longer. Please, don’t give up. Thank you for advocating. I cannot do it for myself or others any longer, and appreciate your efforts!